Showdown Looms in Congress Over Drug Advertising on TV

Direct to consumer drug advertising is a U.S. phenomenon (with the exceptionof New Zealand drug ads are verboten). In the U.S. the prescription drugindustry spent $4.5 billion last year to advertise its mostly clinicallyunremarkable drugs–many advertised drugs pose risks of harm far moreserious than the conditions for which they were prescribed.

The New York Times reports that industry itself acknowledges having an imageproblem. “It would be naïve to not acknowledge the fact that D.T.C. advertising isalso a lightening-rod in the health care debate in this country,” said BillyTauzin, the former congressman who is now president and chief executive ofthe Pharmaceutical Research and Manufacturers of America, in a speech toventure capitalists last spring. There is “one great problem” that themanufacturers face, he said: “in a word, it is trust.”

That loss of public trust has been fully earned by an industry that marketsdrugs through deceptive practices. As their internal documents reveal, BigPharma companies market their drugs by inflating minimal benefits andconcealing very substantial, lethal risks of harm.

THE NEW YORK TIMES January 22, 2007 Showdown Looms in Congress Over Drug Advertising on TV

By MILT FREUDENHEIM

Drug advertising aimed at consumers, a fast-growing category that reached$4.5 billion last year, will face hard scrutiny in the new Congress,according to industry critics in both the House and Senate.

The consumer ads will be on the griddle early in this session at hearings onthe user fees that manufacturers pay to speed the reviewing of new drugs bythe Food and Drug Administration. The user fee law will die in the fallunless Congress acts to renew it.

The pharmaceutical industry, which often gets what it asks for from Congressand the executive branch, seeks to renew the law and add a new set of userfees that would be pay salaries for additional F.D.A. employees to evaluateall consumer drug ads, before they are shown on television.Both the industry and its critics agree that there should be a pause beforethe advertising starts — to allow time for doctors to learn about a newdrug. The companies want the delay to be left up to them, but critics say theF.D.A. should require a wait of up to two years. Criticism ofdirect-to-consumer advertising has intensified since 2004, after Merckwithdrew Vioxx, a heavily advertised painkiller, after a clinical trialshowed that it sharply increased the risk of heart attacks and strokes.

“From the beginning , everyone, including the company, agreed that noteverybody ought to be getting Vioxx,” said Helen Darling, president of theNational Business Group on Health, an organization of large employers. “Butthe ads implied there was a widespread need for it.”

Spending on consumer drug advertising, meanwhile, has been growing robustly,from $1.1 billion in 1997 to $4.2 billion in 2005, according to a recentreport to Congress by the Government Accountability Office . In the firstnine months of 2006, spending rose 8.4 percent to $3.29 billion, on tracktoward $4.5 billion for the year, according to TNS Media Intelligence, anadvertising research firm.

Spending on the ads faltered in 2005 after soaring 27 percent in 2004,before Vioxx was withdrawn, said David Kweskin, a senior executive at thefirm. “Now they are in a catch-up phase.”

Two independent government watchdog groups sharply criticized consumer drugadvertising recently, and a separate survey Jan. 9 commissioned by thePricewaterhouseCoopers accounting and consulting firm indicated thatskepticism is widespread among the public, too. Only 1 in 10 consumers saidthe direct-to-consumer, or D.T.C., ads could provide useful information to alarge audience, the survey said. (Consumer drug advertising is not permittedin most of the world, except New Zealand and the United States.)

The pharmaceutical industry itself acknowledges having an image problem. “It would be naïve to not acknowledge the fact that D.T.C. advertising isalso a lightening-rod in the health care debate in this country,” said BillyTauzin, the former congressman who is now president and chief executive ofthe Pharmaceutical Research and Manufacturers of America, in a speech toventure capitalists last spring. There is “one great problem” that themanufacturers face, he said: “in a word, it is trust.”

Mr. Tauzin’s organization issued voluntary guidelines for consumer ads,which took effect last year. Under the guidelines, the companies havepromised to hold off on consumer advertising of a new medicine for anunspecified “appropriate” period. That would allow time to tell doctorsabout risks and benefits, before television and Web site viewers see an adand demand a prescription.

Twenty-seven members of the pharmaceutical manufacturers organization haveendorsed the guidelines, but it is hard to figure exactly how long thedelays in advertising will run. Bristol-Myers Squibb has said that it woulddelay for 12 months. Johnson & Johnson and Pfizer said they would wait sixmonths. The manufacturers group cannot say how other companies haveinterpreted the guidelines, a spokesman said.

But according to TNS Media Intelligence, the companies have actually beenwaiting 15 months, on average, since the Vioxx debacle.Critics say that even after F.D.A. approval, the full safety profile of anew drug cannot be known until it has been widely used for a number ofyears. But the manufacturers’ guidelines have to be voluntary, said Daniel E. Troy,a former chief counsel of the F.D.A., because the Supreme Court has “struckdown restrictions on advertising of tobacco, alcohol, gambling andunapproved compounded drugs.”

The agency sent 15 warning letters to drug companies regarding ads in 2005and a total of 22 complaints last year. The F.D.A. told AstraZeneca, for example, to “immediately cease” a“misleading superiority claim” in a 2005 TV commercial. The ad saidAstraZeneca’s Crestor was “clearly the best” in a “head to head” test withthe three largest-selling cholesterol drugs. Emily Y. Denney, an AstraZeneca spokeswoman, said that by the time theletter was received, in March 2005, the ads were no longer running. Thecompany defended its message in the advertising as “appropriate.”

Another F.D.A. letter told Amgen, a biotechnology company, to stop runningcommercials for Enbrel, a treatment for the skin disease psoriasis, that theF.D.A. said minimized “serious risks” associated with the drug. Amgenimmediately withdrew the commercial.

Last year, the company obtained F.D.A. approval of the contents of a newEnbrel television ad before showing it, David Polk, an Amgen spokesman said.Corporate lawyers say such advertising is protected by the First Amendmentunder a doctrine of commercial free speech. But some experts say the limitsof the protection are murky.

The closest approach to clarity was in 2002 when the Supreme Court rejected,by a 5-to-4 vote, a federal restriction on advertising by pharmacists whomake their own compounds.

“It is a giant game of chicken between the government and the industry,”said R. Alta Charo, a law professor and bioethics specialist at theUniversity of Wisconsin in Madison. “I don’t believe either side reallywants to see a definitive case go to the Supreme Court because neither sideis willing to take the risk that they will lose.”

Professor Charo was a member of a committee of experts of the Institute ofMedicine, which examined drug safety issues at the request of the F.D.A.Last fall, the committee called on Congress to give the F.D.A. new authorityover advertising, including the power to require a two-year moratorium onadvertising before approving a new drug.

“I think the Congress has clearly indicated its strong interest and concernsabout the F.D.A. and drug safety for consumers,” said Sheila P. Burke, alongtime Republican health policy expert who headed the Institute ofMedicine committee. “Broad-scale advertising can sometimes lead to a rapidincrease in the use of a drug” that raises the risk of harm for patients,she said.

F.D.A. regulators would be granted the power to require moratoriums under abill sponsored by Senators Edward M. Kennedy and Michael B. Enzi, thechairman and ranking Republican member of the Senate Health, Labor,Education and Pensions Committee.

“Patients deserve the best and most accurate information about the medicinesthey take,” Senator Kennedy said in a statement. “An essential part of anydrug safety proposal must be to give the F.D.A. the authority and resourcesit needs to oversee direct-to-consumer advertising, and to allow the F.D.A.to impose conditions or limits on that advertising, where needed to protectthe public health."

Testifying for the pharmaceutical industry last year, Dr. Adrian Thomas, avice president of Johnson & Johnson, insisted that “the important FirstAmendment issues that arise from banning truthful speech, even for a periodof time, must be carefully considered before legislating in this area.”

The Government Accountability Office said last November that the F.D.A.should be doing a better job of overseeing consumer drug ads. Now, theF.D.A. reviews only a small fraction of the advertising, picking andchoosing without proper priorities, the G.A.O. said.

The G.A.O. report had been requested by three influential senators: BillFrist, a doctor, before he stepped down as Republican leader of the Senate;Charles E. Grassley , now the ranking Republican on the finance committee,and Herb Kohl, a Democrat who heads an appropriations subcommittee thatoversees the F.D.A.

Representative Henry A. Waxman, a California Democrat who is chairman of theHouse Oversight and Reform Committee, added a further criticism: that theF.D.A. had been slow to crack down on drug ads that included “false andmisleading” claims, he said in a telephone interview.

F.D.A. officials said they had to deal with 54,000 drug promotions eachyear, aimed at both doctors and consumers. * “We are seriously considering all of the recommendations” of the Instituteof Medicine report, said Thomas Abrams, director of the F.D.A.’s division ofdrug marketing, advertising and communications.